FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 24, 2025, 09:48 UTC 53 0 comments Labeling changes approved for PHARMOBEDIENT. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE FDA Approval Dec. 24, 2025, 09:48 UTC 51 0 comments Labeling changes approved for AM REGENT. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA approves MUCINEX 12 HR COLD & FEVER MULTI-SYMPTOM from RB HLTH FDA Approval Dec. 23, 2025, 22:37 UTC 57 0 comments Final approval of NDA #NDA #217338 for DEXTROMETHORPHAN/GUAIFENESIN/NAPROXEN SODIUM. Decision date: 12/22/2025 Comment Full text
FDA approves OZILTUS from AMNEAL PHARMS LLC FDA Approval Dec. 23, 2025, 18:04 UTC 54 0 comments Final approval of BLA #BLA #761457 for DENOSUMAB. Decision date: 12/19/2025 Comment Full text
FDA approves BONCRESA from AMNEAL PHARMS LLC FDA Approval Dec. 23, 2025, 18:04 UTC 52 0 comments Final approval of BLA #BLA #761456 for DENOSUMAB. Decision date: 12/19/2025 Comment Full text
FDA approves WEGOVY from NOVO NORDISK INC FDA Approval Dec. 23, 2025, 13:40 UTC 52 0 comments Final approval of NDA #NDA #218316 for SEMAGLUTIDE. Decision date: 12/22/2025 Comment Full text
FDA approves HALOPERIDOL from CREEKWOOD PHARMS FDA Approval Dec. 23, 2025, 09:48 UTC 54 0 comments Final approval of ANDA #ANDA #218162 for HALOPERIDOL. Decision date: 12/18/2025 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN from TEVA PHARMS USA INC FDA Approval Dec. 23, 2025, 09:48 UTC 30 0 comments Tentative approval of ANDA #ANDA #211541 for DAPAGLIFLOZIN. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for ZINGO FDA Approval Dec. 23, 2025, 09:48 UTC 33 0 comments Labeling changes approved for POWDER PHARMS. Active ingredient: LIDOCAINE HYDROCHLORIDE. Decision date: 12/19/2025 Comment Full text
FDA updates labeling for PROSTIN VR PEDIATRIC FDA Approval Dec. 23, 2025, 09:48 UTC 34 0 comments Labeling changes approved for PFIZER. Active ingredient: ALPROSTADIL. Decision date: 12/22/2025 Comment Full text